Global Head of Patient Safety Operations

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Who We Are The Product Development Safety (PDS) organisation delivers patient-centric solutions that build trust and create value for society, leading smarter safety design and decision-making activities throughout the lifecycle. PDS sustains Pharmacovigilance (PV) system compliance and quality, to foster trust and drive efficiency while innovating and improving the capabilities that address the evolving priorities of our enterprise.

The Global Head of Patient Safety Operations is a pivotal role for the organisation and is leading the building and implementation of the Patient Safety Operations strategy, driving industry leading global and regional operational excellence. You will be accountable for the execution of key safety processes that are essential to meet regulatory requirements, aid scientific analysis and advance the delivery of patient centric safety.

In this role you drive and strategically lead priorities for Patient Safety Operations across multiple locations supporting the overall PDS Strategy. You lead and empower the Patient Safety Operations team and ensure efficient, cost effective, high quality and compliant delivery of operational activities, establishing beneficial relationships with vendors supporting the Patient Safety Operations deliverables. As the Global Head of Patient Safety Operations you will be a member of PDS’ leadership team, ensuring the effectiveness of PDS on a day-to-day basis and for impactful long-term strategic programmes.

Delivery of above-country safety operational activities, ensuring consistent execution, globally and across regional hubs, including (but not limited to):
Leading Patient Safety Operations Teams responsible for Individual Case Safety reports (ICSR) and medical device safety report collection, processing, and reporting, including associated quality and training activities. Collaborating closely with stakeholders including International Patient Safety (IPS) Global Head and Regional Heads, Affiliate Safety Leaders to ensure operational requirements, and identification of further opportunities and innovation. Collaborating closely with Roche technology organisations and technology vendors to maximize technological performance while driving cost optimisation.

Working closely with the Global Process Owners and Business Process Owners to ensure up-to-date processes and procedures. Providing vigilance expertise on operational processes to stakeholders including clinical, development and marketing teams. Consulting on safety data collection obligations from all sources of Roche Pharma products and modalities, classification and assessment of global digital activities, review of eCRFs for clinical trials, PV approval for global Market Research and Patient Support Programs.

Negotiating, implementing and establishing safety agreements (eg. PVAs, SDEAs, Safety Management Plans etc) with partners. Leading and guiding Regulatory Reporting Services Team accountable for contributing information to the global Safety Regulatory Document Preparation process. PDS performance standards within Patient Safety Operations moving towards quality and compliance as a competitive advantage:
Ensuring tasks are performed according to international regulatory requirements, internal standards and in alignment with PDS strategies. Achieving defined performance metrics for patient safety operations processes. Ensuring Patient Safety Operations function is inspection ready, assisting PDS and Pharma Development (PD) Quality during inspections and audits. Partnering with PD and Pharma stakeholders to set clear data standards for provision of information, facilitating high quality compliant safety data processing.

Continuous improvement activities in pharmacovigilance, particularly in relation to safety operations processes:
Identifying necessary changes to policy, process or organisation to improve compliance, quality and efficiency, proposing changes to the Global Process Owner and/or PDS Leadership Team and/or Good Vigilance Practice Council, and driving implementation of agreed change. Establishing and implementing best practice sharing in pharmacovigilance activities and identifying and implementing continuous improvement activities in support of operational PV. In collaboration with PDS vendor management responsibles, developing and implementing operational sourcing strategies to optimise cost, capacity, quality, and performance by finding the right balance…